Anti-aging human study wins FDA approval 

New drug study approved by FDA

The FDA has approved human trials for the diabetes drug, metformin, which claims to enhance and expand the healthy human life span. The potential is huge but, as usual, its not that simple.

Metformin, a Not So New Drug, May Mean Healthier Lives

Metformin was approved in England in 1957 as a generic diabetes drug, known for its blood sugar–lowering properties and for being quite safe. Right now it costs about 35 cents per pill and it used around the world. It has also been found to postpone the aging process in animal studies and that is what has some people excited.

It is important to note that metformin alone will not make it possible for humans to live to 120. What actually does is allow humans to age better — thus preventing degenerative diseases that can cause earlier deaths. The drug enhances the activity of an enzyme found within cells called adenosine monophosphate-activated protein kinase (AMPK). According to proponents of the drug, AMPK activation helps mimic the beneficial effects of calorie restriction, when cells go into a semi-starvation mode and increase their survival efficiency. Life Extension, a consumer-based organization dedicated to finding new scientific methods to enhance and expand the healthy human life span, believes that consistent calorie restriction is the best documented method of slowing and reversing biomarkers of human aging.

According to them, people under age 60 who regularly and vigorously exercise boost their AMPK levels. They think it is this process by which exercise markedly lowers cancer risk. But as people age past 60, exercise may not adequately boost AMPK enzyme activity, hence the need for pharmaceutical assistance to continue to stave off aging and the diseases that come with it.

Even with FDA Approval, Study hasn’t started

In June, Dr. Nir Barzilai, a scientist based in the Albert Einstein College of Medicine in New York City’s Bronx borough, along with academics from the not-for-profit American Federation for Aging Research (AFAR), went the Food and Drug Administration to propose the Targeting Aging With Metformin (TAME) study, to see if metformin could do for humans what it does for animals. Its the first clinical trial to test if a drug could slow human aging.

Although the FDA said yes, according to Newsweek no one has agreed to front the capital required to get TAME started. As the article points out, that’s not too surprising.  Pharmaceutical companies don’t have a ton of interest in slowing the onset of degenerative and chronic diseases that currently make them a lot of money.  Especially when the solution is a cheaply available, common drug.

For it to be financially feasible a pharmaceutical company would need to test metformin in clinical trials and get it approved for anti-aging so that they would be the only one allowed to use it for that purpose during the patent period. However, for that to happen the FDA would have to do something it’s never done: approve an anti-aging indication for a drug. It remains to be seen how this will play out.

Other Pharmaceutical Efforts to Live Longer

According to the article in Newsweek, Metformin isn’t the only effort to extend human lives. Google, who seems to have their fingers in everything launched Calico in 2013, a billion-dollar anti-aging research and development arm. Last year Calico formed a partnership with pharmaceutical giant AbbVie to increase their likelihood of success. Novartis is also working on the issue. They are developing a patentable form of rapamycin—a biological agent discovered in the soil on Easter Island—which has been shown to boost immune function. The company hopes it will become the first viable anti-aging pill and allow them to get a jump in to what could be a huge new industry.

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Lindsey McCoy MPA, is an Executive Medical Recruiter and former CEO in the not for profit sector.

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